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FDA 510(k)

Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B

K-Number: K222994 · 2023-07-26

Decision Date2023-07-26
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B is a medical device manufactured by Shenzhen AOJ Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-26 under approval number K222994. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B?

Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B is a medical device that received FDA 510(k) clearance on 2023-07-26. It is manufactured by Shenzhen AOJ Medical Technology Co., Ltd.. The 510(k) number is K222994.

When was Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B approved by the FDA?

Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B received FDA 510(k) clearance on 2023-07-26, under approval number K222994.

What company makes Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B?

Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B is manufactured by Shenzhen AOJ Medical Technology Co., Ltd..

What is the FDA product code for Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B?

The FDA product code for Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B is DXN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.